Program Manager
Program Manager
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$ 110000 - 140000
1 Vacancy
Job Description
Neurotech Pharmaceuticalsis an innovative biopharmaceutical company located in Cumberland RI and Needham MA within Greater Bostons vast biotechnology landscape. Since our inception more than 20 years ago we have been developing a proprietary drug delivery platform for treatment of a variety of retinal disorders. Our drug delivery platform Encapsulated Cell Technology (ECT) platform is designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel). For over two decades we have pioneered the development of our proprietary Encapsulated Cell Therapy (ECT) platform designed to address chronic retinal diseases. Our lead program focuses on Macular Telangiectasia Type 2 (MacTel) a rare retinal disorder leveraging ECTs innovative approach to provide sustained targeted treatment directly to the eye. We are excited to expand our company from a research organization to a commercial entity following recent positive rendering from the FDA.
We are seeking a highlymotivated Program Manager to work closely with Technical Development Manufacturing Regulatory Supply Chain and Quality to actively manage projects to completion. The successful candidate will play a key role in leading projects in conjunction with the Quality Department related to the manufacture and release of the NT501 product.
Job Requirements
- Lead crossfunctional teams to plan coordinate and execute pharmaceutical projects ensuring compliance with cGMP FDA ICH and other regulatory standards.
- Develop and maintain detailed project plans timelines and budgets ensuring alignment with quality and regulatory requirements for drug development validation and manufacturing processes.
- Drive project meetings by issuing agendas minutes tracking action items and documenting key decisions ensuring traceability for regulatory inspections and audits.
- Identify and mitigate project risks related to regulatory approvals quality control and manufacturing scaleup escalating critical issues in a timely manner.
- Collaborate with Regulatory Affairs Quality Control Quality Assurance Product Development and Manufacturing to ensure project milestones align with compliance and business objectives.
- Oversee and track progress of validation stability studies process improvements and technology transfers ensuring adherence to ICH Q10 (Pharmaceutical Quality System) principles.
- Prepare and present status reports risk assessments and project reviews to senior leadership and stakeholders.
- Participate in the development and refinement of project management best practices including the creation of templates workflows and process optimizations for quality system improvements.
- Ensure all project documentation is auditready aligning with cGxP and data integrity (ALCOA) principles.
- Support regulatory submission activities ensuring projects meet required milestones for ANDA NDA or BLA filings as applicable.
Education and Experience
- Technical degree (Engineering or Science) with a BS and 4 years of program management experience in a pharmaceutical or biotechnology company. PMP certification is a plus.
Knowledge Skills and Abilities
- Demonstrated experience in project management within a pharmaceutical setting.
- Demonstrated experience with medical device biologic or combination device.
- Demonstrated experience working with Quality Control and Quality Assurance teams.
- Strong knowledge of project management tools/software (Microsoft Project or Smartsheet) statistical analysis and digital solutions.
- Excellent judgment and ability to communicate issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written).
- Ability to effectively collaborate in a dynamic crossfunctional matrix environment.
- Ability to adapt to new and challenging project implementation strategies of varying scope and complexity.
- Proven ability to drive results and influence/mediate resolutions of project roadblocks.
- Familiarity with current Good Manufacturing Practices (cGMP) and compliance issues for products manufactured by aseptic processing.
- Demonstrated ability to multitask manage multiple stakeholder interactions and work effectively with team members in a fastpaced environment.
- Possess the presentation skills necessary to influence and inform scientific decisions at senior management crossfunctional or external meetings.
- Excellent interpersonal and leadership skills including strategic planning negotiation and conflict management.
In addition to a talented and passionate team of colleagues and unparalleled science and technology Neurotech offers competitive compensation benefits through Blue Cross BlueShield and HealthEquity (FSA HAS & HRA) a 401(k) through Fidelity with a companysponsored match generous vacation time and company holidays. And thats just the beginning.
Do you share our vision
To apply please send a copy of your rsum to .
Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.
Additionally Neurotech does not accept unsolicited rsums or candidate profiles. If a candidate submitted in this manner is hired no placement fee will be paid.
Required Experience:
Manager
Employment Type
Full-Time
